3904. Misbranding of Special Formula tablets and Miller's Compound tablets.
U. S. v. 1 drum, etc.    (F. D. C. No. 31642.    Sample No. 3396-L.)
LIBEL FILED :    On or about September 19,1951, Eastern District of Virginia.
ALLEGED SHIPMENT :    On or about April 20, 1951, by the National Drug Co., from
Philadelphia, Pa.
PRODUCT : 1 drum containing 35,000 Special Formula tablets, and 10 bottles, each
containing 50 tablets, of Miller's Compound tablets, at Richmond, Va., in the
possession of T. A. Miller Co., Inc., together with a number of loose bottle
labels.
RESULTS OF INVESTIGATION : The tablets in the bottles had been repackaged, by
the consignee, from drums of Special Formula tablets included in the above-
mentioned shipment.
LABEL, IN PART: (Drum) "Special Formula No. A-2343 Rx Compressed
Tablets Resorcin 1 gr. Powd. Rhubarb Equiv. 2 grs. Sodium Sulfate
Dried 2 grs. Bismuth Subsalicylate 2 grs." and (bottle) "Tablets Miller's
Compound Resorcin Bismuth and Rhubarb Tablets (An Antacid and Mild
Laxative). Active Ingredients: Resorcin, Bismuth Subsalicylate, Sodium
Sulphate, Rhubarb."
NATURE OF CHARGE: Misbranding (tablets in drum and bottles), Section 502
(f) (1), the labeling of the article failed to bear adequate directions for use.
The article was misbranded in this respect when introduced into and while
in interstate commerce.
Misbranding (tablets in bottles), Section 502 (a), the label statements "(An
antacid and Mild Laxative) Active Ingredients: Resorcin * * * Sodium
Sulphate, Rhubarb. * * * For Indigestion * * * As a Laxative in Constipa-
tion * * * To avoid dependence on laxatives take only when needed" were
false and misleading since resorcin, sodium sulfate and rhubarb would con-
tribute nothing to the antacid effects of the product; the article was not an
adequate and effective treatment for all types of indigestion; and it was not
a laxative; and the label statement "Active Ingredients: Resorcin, Bismuth
Subsalicylate, Sodium Sulphate, Rhubarb" was false and misleading since
bismuth subsalicylate was the sole active ingredient of the article. Further
misbranding, Section 502 (f) (1), the labeling of the article failed to bear ade-
quate directions for use as an antacid. The article was misbranded in these
respects while held for sale after shipment in interstate commerce.
DISPOSITION : September 9, 1952. Default decree of condemnation and
destruction.